Sutent gets FDA approval for early use in kidney cancer

Decision could help Pfizer combat competition from BMS' Opdivo and Yervoy

Pfizer has been granted FDA approval for use of its Sutent drug to prevent recurrence in patients undergoing surgery for kidney cancer, around two months earlier than expected.

The US regulator gave the nod to the drug late last week for adjuvant treatment of patients with renal cell carcinoma (RCC) - the most common form of kidney cancer - despite a split vote from its Oncologic Drugs Advisory Committee in September.

First launched in 2006, kinase inhibitor Sutent (sunitinib malate) is Pfizer’s second-biggest cancer drug, bringing in $805m in sales in the first nine months of 2017 but has started to contract a little thanks to increased competition in the marketplace. Last year it made $1.09bn, just passing the border into blockbuster territory.

It has been the first-line drug of choice for RCC for several years, but its position is now being threatened by new immuno-oncology drugs, including Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) combination which became the first regimen to outperform Sutent in first-line RCC when the results of the CheckMate-214 study were reported in September.

Approval in the adjuvant setting opens up a new patient population for Sutent, which is the first drug to be approved for this indication by the FDA, and is “significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning”, commented the agency’s head of oncology Richard Pazdur.

“There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence,” he added.

The approval is based on the S-TRAC trial, which showed that after five years, 59.3% of patients treated with Sutent had not experienced cancer recurrence or death compared with 51.3% of patients receiving placebo. That was the first study to show a benefit of adjuvant RCC therapy, but comes against a trade-off of a much higher level of side effects.

The labelling for Sutent contains a boxed warning to alert healthcare professionals and patients about the risk of severe liver damage (hepatoxicity), which may result in liver failure or death, notes the FDA.

RCC kills more than 100,000 people worldwide each year and is associated with a five-year survival rate of around 12%. While most first-line therapies such as kinase drugs provide a short-term benefit they eventually lose their efficacy.